Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company announced that Livalo (pitavastatin) tablets is now available in retail pharmacies throughout the United States. Livalo, a statin medication approved by the US Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. Livalo is available in doses of 1 mg, 2 mg and 4 mg.

Livalo, approved on the basis of 10 clinical trials, including five 12-week clinical trials comparing efficacy and safety to three currently FDA-approved statins (atorvastatin, simvastatin, and pravastatin), offered LDL cholesterol (LDL-C) lowering of up to 39 per cent at a 2 mg dose and up to 45 per cent at a 4 mg dose.

While few drugs, including Livalo, are free from drug-drug interactions, Livalo may be an attractive option for physicians treating patients taking multiple medications because its potential for cytochrome P450-mediated drug-drug interactions is low. Livalo is only minimally metabolized by the cytochrome P450 system in the liver, which is important because this system is involved in approximately 75 per cent of all drug metabolism.

"Since many patients treated for elevated cholesterol may be on multiple medications, it is important that physicians and pharmacists caring for these patients understand how treatment with a cholesterol medication, such as a statin, may potentially interact with the other drugs the patient may be taking," said Michael Davidson, M.D. director of preventive cardiology, University of Chicago Pritzker School of Medicine.

"Livalo has been the leading product in our cardiovascular portfolio in Asia since 2003," said Ben Stakely, president and CEO of Kowa Pharmaceuticals. "We are excited to bring our flagship product to the US to help patients reach their LDL-C goals."

"Lilly is committed to providing innovative solutions to patients in need and is excited to collaborate with Kowa Pharmaceuticals America, Inc. to bring this new statin to the market," said Javan Collins, vice president of Cardiovascular Business Unit, Lilly. "Livalo offers physicians another option for patients trying to lower their LDL-C."

Kowa Pharmaceuticals and Lilly last year announced a co-promotion agreement to commercialize Livalo in the US in which both companies will provide sales force resources and share development and commercialization costs.

Livalo is a synthetic statin developed in Japan. The efficacy of Livalo has been evaluated against atorvastatin, simvastatin, and pravastatin in patients with primary hyperlipidemia or mixed dyslipidemia. In these studies, Livalo was evaluated in patients with type II diabetes, patients 65 years and over, and patients with two or more risk factors for coronary artery disease. Livalo is only minimally metabolized by the liver cytochrome P450 enzyme system, which may help reduce its potential for drug-drug interactions mediated by this system.

Since its launch in Japan (2003), South Korea (2005), Thailand (2008) and China (2009), Livalo has been successfully used in these countries to treat elevated cholesterol.

An elevated level of cholesterol in the blood is called hypercholesterolemia, commonly referred to as high cholesterol. It can be also defined as hyperlipidemia (high levels of fatty substances in the blood). High level of triglycerides also falls under this category. Mixed dyslipidemia is usually marked by an elevation of total cholesterol, LDL-C, and triglyceride (TG) levels and a decrease in HDL-C in the blood.

Despite the availability of treatments in the U.S., there is still a need for more options to help treat elevated cholesterol. According to the American Heart Association, approximately one out of every three American adults has an LDL-C level of 130 mg/dL or higher, which is a major risk factor for coronary heart disease (CHD) and stroke. In addition, less than half of patients who qualify for any kind of lipid-modifying treatment are receiving it, and only about one-third of patients who are on treatment are achieving their LDL-C goals.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.